The Operational Quality Manager provides quality oversight and guidance to the designated Autonomous Production team (APT) or area of responsibility, on all aspects of Shopfloor / operational activities. The incumbent is accountable for quality and compliance of licensed products, in alignment with Sanofi Pasteur Quality Standards, Quality Systems, and current Good Manufacturing Practices.  The incumbent is expected to work independently with a high level of autonomy and authority for decision making.

This position requires strong collaboration and communication with key responsible Partners in the APT, and with other stakeholders across the organization, including within OQ-SA, Validation Services, Product Quality, QC and Quality Systems, MTech and ETS.

• Provides coaching and leadership to shopfloor staff, assuring that processes are executed effectively, compliantly and thereby enabling and promoting a Quality culture.

• Partners with production and operates with strong process knowledge and risk-based decision making, required on the shopfloor to support cGMP compliance.

• Responsible for timely and thorough deviation investigations, guiding the investigation team as required throughout the investigation process (problem definition, scope, investigation strategy, RCA, CAPAs) and ensures that batch decisions are compliance and science-based, and supported by strong data driven justification.

• Ensures timely review and approval of deviations, SOPs, CAPAs, ERs and other GxP documents such as Master Batch Production Records, operational log books, sterilization and depyrogenation records, work orders, worksheets, maintenance task lists, change control assessments and approvals, and protocols/ reports that are within the scope or delegated.

• Participates as QO Representative at various committees and boards such as: Sanofi Pasteur Change Control Board, Deviation Review Board, +QDCI, FFast, etc.

• Participates in self-inspections, periodic internal reviews/audits to ensure compliance procedures are followed, and participates in external audits/inspections.

• Identifies and mitigates risks, and leads Shopfloor Quality improvement within the APT and more broadly as applicable.

• Ensures alignment to Global and new Regulatory requirements, participating in gap remediations, compliance and Site Projects as required.

• Support the OQ Deputy Director (as required) in the following (but not limited to) assessing and approving Process at Risk (PAR) forms, Provision batches in the eBAR for financial month end.

• Scope may be one of the following Operational areas (but not limited to): cP, DTPPD/ Adsorption, Formulations, Filling and Packaging (FF&P), QC, Technical Services at the Toronto Site

• Scope includes from seed to final packaged vials.

• Position liaises across all Industrial Affairs departments, RA, other Sanofi-Pasteur sites (as required).

• Freedom to act, level of autonomy: Position has a high degree of autonomy and is expected to make decisions and interpretations within broadly defined requirements.

• Bachelor of Science specializing in Microbiology, Biochemistry, Immunology or Pharmacology with 5 or more years of relevant experience in a pharmaceutical or biological manufacturing environment.

• Experience interacting with regulatory agencies and health authority inspections is required.

• Strong leadership and management capability

• Excellent knowledge of cGMPs, compliance trends and vast amount of experience with inspections/audits

• Excellent problem solving (root cause analysis), investigation skills

• Strong influencer and communicator

• Solid experience with continuous improvement methodologies and risk-based approaches

• Act for Change - 10%

• Cooperate Transversally - 20%

• Commit to Customers - 10%

• Strive for Results - 25%

• Think Strategically - 10%

• Make Decisions - 25%

Pursue Progress

Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com!

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

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#GD-SP #LI-SP

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!